The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Heliosit-orthodontic.
| Device ID | K823409 |
| 510k Number | K823409 |
| Device Name: | HELIOSIT-ORTHODONTIC |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | VIVADENT (USA), INC. 175 Pineview Dr. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett VIVADENT (USA), INC. 175 Pineview Dr. Amherst, NY 14228 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-15 |
| Decision Date | 1983-01-21 |